← Product Code [MZO](/productcode/MZO) · K262156

# Anti-HCV Next (K262156)

_Abbott Laboratories · MZO · Sep 23, 2026 · Microbiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K262156

## Device Facts

- **Applicant:** Abbott Laboratories
- **Product Code:** [MZO](/productcode/MZO.md)
- **Decision Date:** Sep 23, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3169
- **Device Class:** Class 2
- **Review Panel:** Microbiology
- **Attributes:** Pediatric

## Indications for Use

The Anti-HCV Next assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human adult and pediatric (18 months through 21 years) serum (collected in serum and serum separator tubes) and plasma (collected in sodium heparin, lithium heparin, lithium heparin separator, sodium citrate, disodium EDTA, tripotassium EDTA, dipotassium EDTA, and dipotassium EDTA separator tubes) on the Alinity i system. The Anti-HCV Next assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of hepatitis C virus (HCV) infection in persons with signs and symptoms of hepatitis, persons at risk for HCV infection, and pregnant women. The test does not determine the state of infection or associated disease. Not cleared for use in screening blood, plasma, cell, or tissue donors.

## Device Story

Anti-HCV Next is a chemiluminescent microparticle immunoassay (CMIA) for qualitative detection of anti-HCV antibodies in human serum/plasma; performed on the Alinity i system. Procedure: sample, streptavidin-coated paramagnetic microparticles precomplexed with biotinylated HCV constructs, and acridinium-labeled conjugates are incubated to form a sandwich; wash cycle; addition of second acridinium-labeled HCV antigen conjugate; final wash; addition of Pre-Trigger and Trigger solutions. Chemiluminescent reaction measured as relative light units (RLU); RLU directly proportional to anti-HCV concentration. Results compared to active calibration cutoff to determine reactive/nonreactive status. Used in clinical laboratories to aid presumptive diagnosis of HCV infection. Benefits include diagnostic support for pediatric and adult populations.

## Clinical Evidence

Clinical study evaluated 256 pediatric specimens (18 months to 21 years). HCV status determined by consensus of comparator and two additional FDA-cleared assays, with HCV RNA testing for indeterminate/reactive results. PPA was 100% (6/6; 95% CI: 60.97-100.00) and NPA was 97.60% (244/250; 95% CI: 94.86-98.90). Supplemental pediatric spiking study (n=59) compared pediatric and adult samples, showing 78% of samples had absolute differences ≤10%.

## Technological Characteristics

CMIA technology; uses streptavidin-coated paramagnetic microparticles, biotinylated HCV constructs, and acridinium-labeled recombinant/peptide conjugates. Reusable multi-patient reagent cartridges. Automated processing on Alinity i system. Qualitative output based on RLU comparison to cutoff. No specific material standards cited.

## Regulatory Identification

A hepatitis C virus (HCV) antibody test is identified as an in vitro diagnostic device intended for use with human serum, plasma, or other matrices as a prescription device that aids in the diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. The test is not intended for screening blood, plasma, cell, or tissue donors.

## Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) The labeling required under § 809.10(b) of this chapter must include:
(i) A prominent statement that the test is not intended for the screening of blood, plasma, and cell or tissue donors.
(ii) Limitations, which must be updated to reflect current clinical practice and disease presentation and management. The limitations must include, but are not limited to, statements that indicate:
(A) When appropriate, the performance characteristics of the test have not been established in populations of immunocompromised or immunosuppressed patients or, other special populations where test performance may be affected.
(B) The detection of HCV antibodies indicates a present or past infection with hepatitis C virus, but does not differentiate between acute, chronic, or resolved infection.
(C) The specimen types for which the device has been cleared, and that use of the test with specimen types other than those specifically cleared for this device may result in inaccurate test results.
(D) Test results are to be interpreted by qualified licensed healthcare professionals in conjunction with the individual's clinical presentation, history, and other laboratory results.
(E) A non-reactive test result may occur early during acute infection, prior to development of a host antibody response to infection, or when analyte levels are below the limit of detection of the test.
(iii) A detailed explanation of the principles of operation and procedures for performing the test.
(2) Design verification and validation must include the following:
(i) A detailed device description, including all parts that make up the device, ancillary reagents required but not provided, an explanation of the device methodology, and design of the antigen(s) and capture antibody(ies) sequences, rationale for the selected epitope(s), degree of amino acid sequence conservation of the target, and the design and nature of all primary, secondary, and subsequent standards used for calibration.
(ii) Documentation and characterization (
*e.g.,* supplier, determination of identity, and stability) of all critical reagents (including description of the antigen(s) and capture antibody(ies)), and protocols for maintaining product integrity throughout its labeled shelf life.(iii) Risk analysis and management strategies, such as Failure Modes Effects Analysis and/or Hazard Analysis and Critical Control Points summaries and their impact on test performance.
(iv) Final release criteria to be used for manufactured test lots with appropriate evidence that lots released at the extremes of the specifications will meet the claimed analytical and clinical performance characteristics as well as the stability claims.
(v) Stability studies for reagents must include documentation of an assessment of real-time stability for multiple reagent lots using the indicated specimen types and must use acceptance criteria that ensure that analytical and clinical performance characteristics are met when stability is assigned based on the extremes of the acceptance range.
(vi) All stability protocols, including acceptance criteria.
(vii) Final release test results for each lot used in clinical studies.
(viii) Multisite reproducibility study that includes the testing of three independent production lots.
(ix) Analytical performance studies and results for determining the limit of blank (LoB), limit of detection (LoD), cutoff, precision (reproducibility) including lot-to-lot and/or instrument-to-instrument precision, interference, cross reactivity, carryover, hook effect, seroconversion panel testing, matrix equivalency, specimen stability, reagent stability, and cross-genotype antibody detection sensitivity, when appropriate.
(x) Analytical sensitivity of the test is the same or better than that of other cleared or approved tests.
(xi) Detailed documentation of clinical performance testing from a multisite clinical study. Performance must be analyzed relative to an FDA cleared or approved HCV antibody test, or a comparator that FDA has determined is appropriate. This study must be conducted using appropriate patient samples, with an acceptable number of HCV positive and negative samples in applicable risk categories. Additional relevant patient groups must be validated as appropriate. The samples may be a combination of fresh and repository samples, sourced from geographically diverse areas. The study designs, including number of samples tested, must be sufficient to meet the following criteria:
(A) Clinical sensitivity of the test must have a lower bound of the 95 percent confidence interval of greater than or equal to 95 percent.
(B) Clinical specificity of the test must have a lower bound of the 95 percent confidence interval of greater than or equal to 96 percent.
(3) For any HCV antibody test intended for Point of Care (PoC) use, the following special controls, in addition to those listed in paragraphs (b)(1) and (2) of this section, apply:
(i) Clinical studies must be conducted at PoC sites.
(ii) Additional labeling must include a brief summary of the instructions for use that are appropriate for use in a PoC environment.

## Predicate Devices

- LIAISON XL MUREX HCV Ab ([P190011](/device/P190011.md))

## Submission Summary (Full Text)

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>
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION

## DECISION SUMMARY

ASSAY AND INSTRUMENT

### I Background Information:

A 510(k) Number

K262156

B Applicant

Abbott Laboratories

C Proprietary and Established Names

Anti-HCV Next

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  MZO | Class II | 866.3169 - Hepatitis C virus antibody tests | Microbiology  |

### II Submission/Device Overview:

A Purpose for Submission:

To obtain clearance to expand the intended use of the Anti-HCV Next assay (cleared under K252424 for adults aged ≥18 years) to include the pediatric population.

B Measurand:

Antibodies to hepatitis C virus (anti-HCV)

C Type of Test:

Qualitative, chemiluminescent microparticle immunoassay (CMIA).

### III Intended Use/Indications for Use:

A Intended Use(s):

The Anti-HCV Next assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human adult and pediatric (18 months through 21 years) serum (collected in serum and serum separator tubes) and

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

https://www.fda.gov/

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plasma (collected in sodium heparin, lithium heparin, lithium heparin separator, sodium citrate, disodium EDTA, tripotassium EDTA, dipotassium EDTA, and dipotassium EDTA separator tubes) on the Alinity i system.

The Anti-HCV Next assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of hepatitis C virus (HCV) infection in persons with signs and symptoms of hepatitis, persons at risk for HCV infection, and pregnant women. The test does not determine the state of infection or associated disease.

Not cleared for use in screening blood, plasma, cell, or tissue donors.

# **B Indication(s) for Use:**

See Intended Use(s) above.

# **C Special Conditions for Use Statement(s):**

Rx – For Prescription use only

# **D Special Instrument Requirements:**

The Alinity i System

# **IV Device/System Characteristics:**

# **A Device Description:**

A chemiluminescent microparticle immunoassay (CMIA) Used for qualitative detection of antibodies hepatitis C virus (HCV). It is a reusable multi-patient use device and in a Professional Healthcare Facility environment.

This product is composed of 4 components which are packaged as a 2-cartridge reagent set: Microparticles, Conjugate 1, Assay diluent, Conjugate 2. See K252424.

# **B Principle of Operation:**

The Anti-HCV Next assay is an automated, combined one-step/two-step immunoassay for the qualitative detection of anti-HCV in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology.

Sample, streptavidin-coated paramagnetic microparticles precomplexed with biotinylated HCV constructs, acridinium-labeled recombinant and peptide conjugates, and assay diluent are combined and incubated. The anti-HCV present in the sample binds to the HCV coated microparticles and to the acridinium-labeled conjugates, forming a sandwich. The mixture is washed. In a second step, additional acridinium-labeled HCV antigen conjugate is added to create a reaction mixture and incubated. Following a wash cycle, Pre-Trigger and Trigger Solutions are added.

The resulting chemiluminescent reaction is measured as a relative light unit (RLU). There is a direct relationship between the amount of anti-HCV in the sample and the RLU detected by the system optics.

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The presence or absence of anti-HCV in the sample is determined by comparing the chemiluminescent RLU in the reaction to the cutoff RLU determined from an active calibration.

Interpretation of the results: Initial Interpretation

|  S/CO | Instrument Interpretation | Retest Procedure  |
| --- | --- | --- |
|  0.00 - < 0.90 | Nonreactive | No retest required.  |
|  0.90 - < 1.00 | Grayzone | Retest in duplicate.  |
|  ≥ 1.00 | Reactive | No retest required.  |

Final Interpretation

|  Initial Result | Retest Result | Result | Interpretation  |
| --- | --- | --- | --- |
|  Nonreactive | No retest required. | Nonreactive | Anti-HCV not detected; does not exclude the possibility of exposure to HCV.  |
|  Grayzone | If 2 results are ≥ 1.00 S/CO | Reactive | Presumptive evidence of anti-HCV; follow medical guidelines for recommendations for supplemental testing  |
|   |  If 2 or 3 results (including initial result) are < 1.00 S/CO | Nonreactive | Anti-HCV not detected; does not exclude the possibility of exposure to HCV.  |
|  Reactive | No retest required. | Reactive | Presumptive evidence of anti-HCV; follow medical guidelines for recommendations for supplemental testing.  |

### C Instrument Description Information:

1. Instrument Name:

The Alinity i system

2. Specimen Identification:

Specimens are automatically identified via a built-in barcode reader or can be manually scanned using the System Control Module.

3. Specimen Sampling and Handling:

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The Alinity i system handles samples using a fully automated, continuous and random-access workflow.

# 4. Calibration:

The Anti-HCV Next Calibrator is sold separately. Calibration data is valid for up to 30 days. See K252424.

# 5. Quality Control:

Anti-HCV Next positive and negative controls are sold separately. QC testing is recommended every 24 hours or upon reagent lot changes to ensure results stay within target ranges. See K252424.

# V Substantial Equivalence Information:

# A Predicate Device Name(s):

LIAISON XL MUREX HCV Ab

# B Predicate 510(k) Number(s):

P190011

# C Comparison with Predicate(s):

|  Device & Predicate Device(s): | K262156 (Candidate device) | P190011 (Predicate device)  |
| --- | --- | --- |
|  Device Trade Name | Anti-HCV Next | LIAISON XL MUREX HCV Ab  |
|  **General Device Characteristic Similarities**  |   |   |
|  Intended Use/Indications For Use | The Anti-HCV Next assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human adult and pediatric (18 months through 21 years) serum (collected in serum and serum separator tubes) and plasma (collected in sodium heparin, lithium heparin, lithium heparin separator, sodium citrate, disodium EDTA, tripotassium EDTA, dipotassium EDTA, and dipotassium EDTA separator tubes) on the Alinity i system. | The LIAISON XL MUREX HCV Ab assay is an in vitro chemiluminescent immunoassay (CLIA) for the qualitative determination of specific antibodies to hepatitis C virus (anti-HCV) in human adult and pediatric (2-21 years) serum and plasma (lithium and sodium heparin, sodium citrate and di-potassium EDTA) samples including separator tubes, on the LIAISON XL Analyzer. It is intended to be used as an aid in the diagnosis of HCV infection. The assay may also  |

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|   | The Anti-HCV Next assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of hepatitis C virus (HCV) infection in persons with signs and symptoms of hepatitis, persons at risk for HCV infection, and pregnant women. The test does not determine the state of infection or associated disease. Not cleared for use in screening blood, plasma, cell, or tissue donors. | be used as an aid in the diagnosis of HCV infection in pediatric subjects and in pregnant women. The test does not determine the state of infection or associated disease. The assay is not intended for use in screening blood, plasma, or tissue donors.  |
| --- | --- | --- |
|  Intended use population | Human adult, pediatric and pregnant women. | Human adult, pediatric and pregnant women.  |
|  Assay Type | Qualitative | Qualitative  |
|  **General Device Characteristic Differences**  |   |   |
|  Technology | Chemiluminescent microparticle immunoassay (CMIA) | Chemiluminescent immunoassay (CLIA)  |
|  Pediatric population | Pediatric (18 months through 21 years) | Pediatric (2-21 years).  |
|  Sample matrix | Serum SST Plasma (sodium heparin, lithium heparin, lithium heparin separator, sodium citrate, disodium EDTA, tripotassium EDTA, dipotassium EDTA, and dipotassium EDTA separator tubes) | Serum Plasma (lithium and sodium heparin, sodium citrate and di-potassium EDTA)  |
|  Calibrator | 1 positive level; recalcified, heat-inactivated human plasma reactive for anti-HCV | Diluted, inactivated serum/plasma with low anti-HCV  |
|  Instrument Platform | Alinity i system | LIAISON XL Analyzer  |
|  Applications/Test Time | - Time to First Result: less than 29 minutes. - Maximum Throughput: Up to 200 tests per hour on the instrument. - Walk-Away Time Up to 5 hours. (minimum 3 hours) | - Time to First Result: 17 minutes. - Maximum Throughput: Up to 171–180 tests per hour on the instrument. - Walk-Away Time: Up to 6 hours.  |
|  Calibration Interval | Recalibrate when: - A new reagent lot is used - QC results fall outside accepted limits - 30 days have passed since last calibration - Critical maintenance or service has been performed | Calibrate using the calibrator in the reagent integral (4 calibrations per solution). Recalibrate in triplicate when: - A new lot of reagent integral or Starter Kit is used  |

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|   |  | • More than 8 weeks have passed since last calibration • The analyzer has been serviced • Control values are outside expected ranges  |
| --- | --- | --- |

# **VI Standards/Guidance Documents Referenced:**

CLSI EP12 3rd Edition: Evaluation of Qualitative Binary Output Examination Performance

# **VII Performance Characteristics (if/when applicable):**

# **A Analytical Performance:**

1. Precision/Reproducibility:

See K252424 Precision/Reproducibility section VII A 1.

2. Linearity:

Not applicable, as this is a qualitative test.

3. Analytical Specificity/Interference:

See K252424 section VII A 3.

4. Detection Limit and Assay Reportable Range:

Not applicable

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

Stability and Expected Values see K252424 section VII A 5.

6. Assay Cut-Off:

See K252424 section VII A 7.

# **B Comparison Studies:**

1. Method Comparison with Predicate Device:

See K252424 section VII C 3.

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# 2. Matrix Comparison:

See K252424 section VII B 2.

# C Clinical Studies:

# 1. Adults and pregnant women clinical study

See K252424 section VII C 3.

# 2. Other Clinical Supportive Data:

# Clinical Performance Study - Pediatric Population

In this submission, Abbott conducted a two-site clinical study to evaluate performance of the Anti-HCV Next assay (Alinity i system) using 124 de-identified pediatric specimens (ages 21 months through 17 years). Of these, 86 (69.4%) were from individuals at risk for HCV infection and 38 (30.6%) were from individuals with signs and symptoms of hepatitis. The assay produced a Negative Percent Agreement (NPA) of 99.17% (119/120; 95% Confidence Interval (CI): 95.43%–99.85%) and a Positive Percent Agreement (PPA) of 100.00% (4/4; 95% CI: 51.01%–100.00%). The results are presented in table 1.

Table 1. Clinical performance results of the Anti-HCV Next in the pediatric population

|  Specimen Category | Number Tested | HCV Status |   |   |   |   |   | PPA (%) (95% CI) | NPA (%) (95% CI)  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  HCV Infected |   | Indeterminate |   | HCV Not Infected  |   |   |   |
|   |   |  R | NR | R | NR | R | NR  |   |   |
|  Pediatric Individuals at Risk for HCV Infection | 86 | 4 | 0 | 0 | 0 | 1 | 81 | 100.00 (4/4) (51.01-100.00) | 98.78 (81/82) (93.41-99.78)  |
|  Pediatric Individuals with Signs and Symptoms of Hepatitis | 38 | 0 | 0 | 0 | 0 | 0 | 38 | NA | 100.00 (38/38) (90.82-100.00)  |
|  Pediatric Individuals at Risk for HCV Infection or with Signs and Symptoms of Hepatitis | 124 | 4 | 0 | 0 | 0 | 1 | 119 | 100.00 (4/4) (51.01-100.00) | 99.17 (119/120) (95.43-99.85)  |

R = Reactive; NR = Nonreactive; PPA = Positive Percent Agreement; NPA = Negative Percent Agreement; CI = Confidence Interval; NA = Not Applicable

# Clinical performance of combined pediatric population from submissions K252424 and K262156

A total of 256 specimens from pediatric individuals with signs and symptoms for hepatitis or at risk for HCV infection were evaluated with the Anti-HCV Next assay. The PPA and NPA are shown in table 2.

Table 2. Clinical performance results of the Anti-HCV Next in pediatric population-combined data (K252424 and K262156)

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|  Specimen Category | Number Tested | HCV Status |   |   |   |   |   | PPA (%) (95% CI) | NPA (%) (95% CI)  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  HCV Infected |   | Indeterminate |   | HCV Not Infected  |   |   |   |
|   |   |  R | NR | R | NR | R | NR  |   |   |
|  Pediatric Individuals at Risk for HCV Infection | 160 | 6 | 0 | 0 | 0 | 6 | 148 | 100.00 (6/6) (60.97-100.00) | 96.10 (148/154) (91.76-98.20)  |
|  Pediatric Individuals with Signs and Symptoms of Hepatitis | 96 | 0 | 0 | 0 | 0 | 0 | 96 | NA | 100.00 (96/96) (96.15-100.00)  |
|  Pediatric Individuals at Risk for HCV Infection or with Signs and Symptoms of Hepatitis | 256 | 6 | 0 | 0 | 0 | 6 | 244 | 100.00 (6/6) (60.97-100.00) | 97.60 (244/250) (94.86-98.90)  |

R = Reactive; NR = Nonreactive; PPA = Positive Percent Agreement; NPA = Negative Percent Agreement; CI = Confidence Interval; NA = Not Applicable.

### Pediatric spiking study

Due to the low prevalence of HCV within the pediatric population, a supplemental spiking study was conducted to determine if equivalent results are obtained in pediatric and adult serum samples on Anti-HCV Next assay. A total of 59 pediatric (aged 17 months to 21 years) and 59 adult negative serum samples were paired and spiked with anti-HCV positive specimens to yield samples at approximately 2 to 3 times the assay cutoff. The distribution of the absolute % differences in signal between the pediatric and paired adult samples is presented in table 3.

Table 3. Pediatric spiking study data

|  Distribution of Absolute Percent Differences in Signal  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  Age Range | N | ≤ 10% | > 10% to ≤ 20% | > 20% to ≤ 30%  |
|  17 Months through 12 Years | 23 | 69.6% | 21.7% | 8.7%  |
|   |   |  (16/23) | (5/23) | (2/23)  |
|  13 through 21 Years | 36 | 83.3% | 11.1% | 5.6%  |
|   |   |  (30/36) | (4/36) | (2/36)  |
|  Total | 59 | 78.0% | 15.3% | 6.8%  |
|   |   |  (46/59) | (9/59) | (4/59)  |

N = Number of samples

### D Expected Values/Reference Range:

See K252424 section E.

### E Proposed Labeling:

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The labeling supports the finding of substantial equivalence for this device.

### VIII Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda-staging.innolitics.com/device/K262156](https://fda-staging.innolitics.com/device/K262156)

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